Phase 4
N=88
Monoamine Contributions to Neurocircuitry in Eating Disorders
Eating Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02020408 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: 5-HT Transporter Binding as Measured During the PET Scan — 1.68; 1.54; 1.46; 1.60 binding potential (BPND) — p=> 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- [11C]raclopride (Drug); [11C]DASB (Drug); amphetamine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Diego
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 5-HT Transporter Binding as Measured During the PET Scan |
1.68; 1.54; 1.46; 1.60; 0.44; 0.35 | > 0.05 |
| SECONDARY Dopamine D2/D3 Receptor Binding as Measured During the PET Scan After Amphetamine Administration |
2.09; 2.01; 1.94; 1.69; 1.62; 1.69 | <0.05 sig |
Summary
This study will use brain imaging technologies to measure several neurotransmitters (serotonin and dopamine) that contribute to our abilities to respond to reward or inhibit our impulses, and which are known to be altered in the brain of people with anorexia nervosa (AN) and bulimia nervosa (BN). Because palatable food stimulates dopamine secretion, we propose to use a challenge with brain imaging that will stimulate dopamine release which we hypothesize will generate anxiety rather than pleasure in AN, and will help explain why AN restrict eating in order to reduce anxiety. This study will help to understand the unique puzzling symptoms in eating disorders and contribute to finding better methods for identifying effective treatments for these often relapsing and sometimes chronic disorders.
Eligibility Criteria
Inclusion
- history of Diagnostic and Statistical Manual (DSM-IV) diagnosis of anorexia or bulimia.
- AN women have history of average body weight (ABW) below 85% for height.
- AN-BN subjects have history of ABW below 85% ABW.
- AN-BN subjects have history of binging/purging behaviors during a period of low weight.
- Subjects must be right-handed.
- Subjects have been recovered for 12 months or more.
Exclusion
- Diagnosis of alcohol or drug abuse or dependence in the 3 months.
- Alcohol or substance use within 30 days.
- Current diagnosis of an Axis I disorder.
- Organic brain syndromes, dementia, psychotic disorders, or mental retardation.
- Neurological or medical disorders such as seizure disorder, renal disease, diabetes, thyroid disease, EKG indicative of electrolyte imbalance
- BN subjects whose purging methods were the use of laxatives, diuretics
- Use of psychoactive medication in the 3 months.
- Pregnancy or lactation.
- Tobacco use in the 3 months.
Data sourced from ClinicalTrials.gov (NCT02020408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.